Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy

Not Applicable

• Conditions: Pancreatic Neoplasm
• Interventions: Other: Difficulty score system for robotic pancreatoduodenectomy

• Registration Number: NCT04662346
• Lead Sponsor: University of Pisa

Brief Summary

Robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. Due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. The ability to predict the depth of robotic pancreatoduodenectomy in each individual patient would be extremely important, for patient selection and for the implementation of the learning curve. This study aims to provide a difficulty score (DS) for robotic pancreatoduodenectomy to be used to select cases based on the experience and expertise of the surgeon.

Detailed Description

Our Robot DIFFICULT Score was developed starting from factors evaluated by surgeons with experience in performing robotic pancreatoduodenectomy in high-volume centers. Based on the univariate and multivariate analysis, the elevated BMI, ASA 3, the need for venous resection and vascular variations in arterial liver supply were considered significant in increasing the degree of "difficulty" in the robotic pancreatoduodenectomy. The Robot ADDICT Score will be calculated in all cases of the International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS; www.i-mips.com).

Study Timeline

• Study First Submitted: 2020-11-30
• Status Verified: 2020-12
• Study Start: 2020-12-01
• Study First Submitted QC: 2020-12-05
• Last Update Submitted: 2020-12-05
• Study First Posted: 2020-12-10
• Last Update Posted: 2020-12-10
• Primary Completion: 2021-01-20
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• pathology of the head of pancreas requiring surgery

Exclusion Criteria

• pathology of the head of pancreas not requiring surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients undergoing robotic pancreatoduodenectomy	Difficulty score system for robotic pancreatoduodenectomy	patients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy

Primary Outcome Measures

Name	Time	Method
correlation to post-operative complication	6 months	the score increase as complications increase

Trial Locations

Locations (2)

Division of pancreatic surgery; 🇮🇹 Pisa, Italy

University of Pisa; 🇮🇹 Pisa, Italy